CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 110 enrolled
Drug / intervention
Lactobacillus rhamnosus GG +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01956916
NCT01956916Phase 3Completed

Effects of LGG Administration in Children With Cystic Fibrosis: A Randomized Controlled Trial

Federico II University·interventional·Posted Oct 8, 2013·Updated Sep 23, 2015

In Brief

A Phase 3 clinical trial evaluating Lactobacillus rhamnosus GG and placebo for Cystic Fibrosis. Completed, enrolled 110 participants across 5 sites.

Detailed Summary

Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI tracts is influenced by both genetic and environmental factors. Children with CF may harbor an abnormal intestinal microflora, because of altered cystic fibrosis transmembrane conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes and acid suppressors). The investigators have previously demonstrated that intestinal inflammation is highly frequent in CF children, being a major feature of intestinal involvement. In addition, specific probiotics significantly improved airway and GI inflammation in a preliminary trial. The investigators aim to characterize intestinal and respiratory microflora in CF patients and to investigate the effects of daily Lactobacillus GG (LGG) supplementation on both GI and airway microflora and the eventual relationship between probiotic assumption and clinical and inflammation markers. The investigators aim is to eventually improve the quality of life of CF patients, who often suffer from intestinal and respiratory progressive disease, through a non invasive intervention consisting in the supplementation of probiotic bacteria.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2013
Enrollment StartOct 1, 2010
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 12.7 years ago

Interventions

Lactobacillus rhamnosus GGdietary

Capsules containing lyophilized 6x10\^9 Colony Forming Units (CFU)/die LGG, (60mg) maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg) 1 cps/die for 12 months

placebodietary

Capsules containing maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg) 1 cps/die for 12 months